September 22, 2016: Hoover Man Charged for Marketing Misbranded Male Enhancement Drugs from China
Hoover Man Charged for Marketing Misbranded Male Enhancement Drugs from China
BIRMINGHAM – Federal prosecutors today charged a Hoover man with receiving and reselling misbranded male enhancement drugs from China that could cause serious side effects in men taking medications containing nitrates, announced U.S. Attorney Joyce White Vance and Food and Drug Administration Office of Criminal Investigation Special Agent in Charge Justin D. Green.
In a one-count information filed in U.S. District Court, the U.S. Attorney’s Office charged NABIL CHAGRI, 38, with one count of receiving and selling or offering to sell a misbranded prescription drug under the name, Zhen Gong Fu, on March 22. The product labeling did not declare that it contained sildenafil citrate, the active ingredient in the prescription drug, Viagra, and made additional false statements. Viagra is FDA approved for treatment of erectile dysfunction. The U.S. Attorney’s Office also filed a plea agreement with Chagri in which he acknowledges the charge and states he will plead guilty to it.
According to the information, drugs containing sildenafil are considered prescription drugs under federal law because of their toxicity and potential for harmful effects, and are considered unsafe for use except under the supervision of a licensed physician.
Sildenafil-containing drugs can be particularly harmful to people taking medications containing nitrates, such as nitroglycerin, because sildenafil can interact with the nitrates and lower blood pressure to dangerous levels, according to the information. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
The Zhen Gong Fu labeling not only failed to disclose that the drug contained sildenafil, it also falsely and misleadingly stated that Zhen Gong Fu “does not affect heart diseases [sic], hypertension or diabetes,” according to the information.
The government’s plea agreement with Chagri states that he received and sold, or offered for sale, a variety of mislabeled male enhancement drugs to wholesale supply stores or gas stations. The drugs, including Zhen Gong Fu, contained sildenafil or tadalafil, the active ingredient in Cialis, another FDA-approved prescription drug for erectile dysfunction.
The assorted mislabeled male enhancement drugs were mailed to Chagri from China at various addresses in north Alabama, according to the plea agreement. Between March 2015 and March 2016, the FDA detained multiple packages containing the drugs in route from China to Chagri and issued eight import detention notices to him, inviting Chagri to challenge the agency’s decision to detain the packages, the plea agreement states.
Chagri received the FDA detention notices, but continued to order and receive the drugs from China, sometimes under fictitious names “in an effort to mislead and evade detection by law enforcement,” according to the plea agreement.